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Temporal Interference Neurostimulation and Addiction

Primary Purpose

Nicotine Use Disorder, Substance Use Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active TI-NDBS

Sham TI-NDBS

tDCS

About this trial

This is an interventional treatment trial for Nicotine Use Disorder focused on measuring Nicotine Addiction, Non-invasive deep brain stimulation, Substance Use Disorders

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Must be between the ages of 18 and 40, must have at least 6th grade education, and the ability to speak and read English, must smoke at least 3/4 of a pack of cigarettes per day, must have phone with internet access.

Exclusion Criteria:

if they are on psychotropic medications for ADHD, other mental illness or medication for cancer, epilepsy (i.e. individuals with any history of seizure disorder), migraines, or other neurological syndromes, or AIDs (which can cause cognitive deficits (Watkins & Treisman, 2015), history of head trauma, history of cognitive impairments, metal implants in the head or under the scalp, personal experiences consistent with symptoms of psychosis (i.e. mind or body being secretly controlled, special powers, seeing or hearing things that aren't really there).
Subjects will be excluded if they do not meet fMRI safety screening criteria (i.e. metal implants in their body, tattoo on head or neck, permanent jewelry, etc.) or if a participant uses an IUD for birth control they will be excluded unless the subject can document the model of the IUD and we can verify its safety for the MRI environment. Pregnancy should be self-reported, and a pregnancy test will not be administered. Participants must also weigh less than 440 lbs.
History of holes bored into skull or known fissures in cranial bones
Presence of pacemakers

Sites / Locations

Indiana UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Sham Comparator

Active Comparator

Experimental

Sham Comparator

Arm Label

Phase 3 Active TI-NDBS

Phase 3 Sham TI-NDBS

Phase 4 Traditional tDCS

Phase 4 TI-NDBS

Phase 4 Sham stimulation

Arm Description

Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation. Participants will receive stimulation for 60 minutes on one day.

Participants assigned to this condition will receive traditional transcranial direct current stimulation for 60 minutes for 5 days.

Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation for 60 minutes for 5 days and will be compared to sham stimulation and tDCS.

Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds. Participants will be in the scanner for 60 minutes for 5 days. This will be used as the control condition and compared with TI-NDBS and tDCS.

Outcomes

Primary Outcome Measures

Change in Nicotine craving

The investigators predict that TI-NDBS will outperform sham stimulation at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with TI-NDBS vs tDCS. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self reported craving.

Change in Nicotine craving due to TI-NDBS compared to tDCS

The investigators predict that TI-NDBS will outperform tDCS at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with one of the stimulation groups vs. sham. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self reported craving.

Secondary Outcome Measures

Full Information

NCT ID

NCT04432064

First Posted

June 5, 2020

Last Updated

May 15, 2023

Sponsor

Indiana University

Collaborators

Indiana University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04432064

Brief Title

Temporal Interference Neurostimulation and Addiction

Official Title

Temporal Interference Neurostimulation and Addiction

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 6, 2020 (Actual)

Primary Completion Date

May 2027 (Anticipated)

Study Completion Date

May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

Indiana University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This project aims to develop a line of research using new non-invasive neurostimulation technology to treat adults with opioid use disorders (OUDs). In the short term, the investigators aim to identify novel target brain regions for neurostimulation treatment and characterize their effects behaviorally and neurally. In the longer term, investigators aim to use these preliminary data to justify NIH sponsored clinical trials to apply transcranial direct current stimulation and non-invasive deep brain stimulation to these areas to partially or completely disrupt addiction.

Detailed Description

The investigators hypothesize that temporal interference non-invasive deep brain stimulation (TI-NDBS) will be well tolerated and effective at manipulating brain activity and reducing drug cravings. The investigators will investigate whether stimulation with a mild current from temporal interference non-invasive deep brain stimulation (TI-NDBS) to the Anterior Cingulate Cortex (ACC), the anterior insula (AI), or the nucleus accumbens (NAcc) will reduce nicotine craving and seeking. The TI-NDBS is similar to the traditional transcranial direct current stimulation (tDCS), a method approved for use in a number of other studies. Other studies have shown there have been some effects of reducing craving with tDCS, however, tDCS cannot stimulate structures such as the ACC very effectively because tDCS cannot stimulate deeper brain regions. Thus, the Specific Aim ultimately will compare TI-NDBS with tDCS and sham stimulation. The study is broken up into four phases. The first two will involve device feasibility and identifying the best locations for the electrodes to be placed. In the third phase, the investigators will compare TI-NDBS with sham stimulation. In the fourth phase, the investigators will compare TI-NDBS with sham stimulation and with tDCS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Use Disorder, Substance Use Disorders

Keywords

Nicotine Addiction, Non-invasive deep brain stimulation, Substance Use Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

One group of 20 participants will receive active TI-NDBS and another group of 20 participants will receive sham TI-NDBS. A third group of 20 participants will receive traditional transcranial direct current stimulation (tDCS).

Masking

Participant

Masking Description

This will be single-blind masking as the experimenter will need to know which intervention to run on the participant.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase 3 Active TI-NDBS

Arm Type

Experimental

Arm Description

Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation. Participants will receive stimulation for 60 minutes on one day.

Arm Title

Phase 3 Sham TI-NDBS

Arm Type

Sham Comparator

Arm Description

Arm Title

Phase 4 Traditional tDCS

Arm Type

Active Comparator

Arm Description

Participants assigned to this condition will receive traditional transcranial direct current stimulation for 60 minutes for 5 days.

Arm Title

Phase 4 TI-NDBS

Arm Type

Experimental

Arm Description

Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation for 60 minutes for 5 days and will be compared to sham stimulation and tDCS.

Arm Title

Phase 4 Sham stimulation

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Active TI-NDBS

Other Intervention Name(s)

Temporal Interference Non-invasive Deep Brain Stimulation

Intervention Description

In the active TI-NDBS condition, subjects will receive stimulation for 60 minutes applied to the brain through scalp electrodes. There will be a maximum of 2 mA per electrode pair and no single region will receive more than 2 mA because the currents will be administered to distinct regions. At the beginning of each stimulation period, the current will increase slowly at a constant rate for 30 seconds until it reaches the appropriate intensity. At the end of the stimulation, the current will decrease slowly for 30 seconds until it reaches zero.

Intervention Type

Other

Intervention Name(s)

Sham TI-NDBS

Intervention Description

This is the control condition in which participants will receive sham stimulation for 60 minutes.

Intervention Type

Device

Intervention Name(s)

tDCS

Intervention Description

This is a well established method of brain stimulation and will be used to compare against the efficacy of TI-NDBS in the reduction of nicotine craving and inhalation. Participants will receive stimulation for 60 minutes.

Primary Outcome Measure Information:

Title

Change in Nicotine craving

Description

Time Frame

Within the first year of testing TI-NDBS in nicotine smokers.

Title

Change in Nicotine craving due to TI-NDBS compared to tDCS

Description

Time Frame

1 year after the first primary outcome.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be between the ages of 18 and 40, must have at least 6th grade education, and the ability to speak and read English, must smoke at least 3/4 of a pack of cigarettes per day, must have phone with internet access. Exclusion Criteria: if they are on psychotropic medications for ADHD, other mental illness or medication for cancer, epilepsy (i.e. individuals with any history of seizure disorder), migraines, or other neurological syndromes, or AIDs (which can cause cognitive deficits (Watkins & Treisman, 2015), history of head trauma, history of cognitive impairments, metal implants in the head or under the scalp, personal experiences consistent with symptoms of psychosis (i.e. mind or body being secretly controlled, special powers, seeing or hearing things that aren't really there). Subjects will be excluded if they do not meet fMRI safety screening criteria (i.e. metal implants in their body, tattoo on head or neck, permanent jewelry, etc.) or if a participant uses an IUD for birth control they will be excluded unless the subject can document the model of the IUD and we can verify its safety for the MRI environment. Pregnancy should be self-reported, and a pregnancy test will not be administered. Participants must also weigh less than 440 lbs. History of holes bored into skull or known fissures in cranial bones Presence of pacemakers

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joshua Brown, PhD

Phone

812-855-9282

jwmbrown@indiana.edu

Facility Information:

Facility Name

Indiana University

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47403

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joshua Brown, PhD

Phone

812-855-9282

jwmbrown@indiana.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will share anonymized participant data upon request. Beyond that, we will report anonymized data publicly in aggregate.

Citations:

PubMed Identifier

18312035

Citation

Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.

Results Reference

background

PubMed Identifier

28575667

Citation

Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.

Results Reference

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PubMed Identifier

24814566

Citation

Fecteau S, Agosta S, Hone-Blanchet A, Fregni F, Boggio P, Ciraulo D, Pascual-Leone A. Modulation of smoking and decision-making behaviors with transcranial direct current stimulation in tobacco smokers: a preliminary study. Drug Alcohol Depend. 2014 Jul 1;140:78-84. doi: 10.1016/j.drugalcdep.2014.03.036. Epub 2014 Apr 16.

Results Reference

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PubMed Identifier

26071624

Citation

Hulvershorn LA, Hummer TA, Fukunaga R, Leibenluft E, Finn P, Cyders MA, Anand A, Overhage L, Dir A, Brown J. Neural activation during risky decision-making in youth at high risk for substance use disorders. Psychiatry Res. 2015 Aug 30;233(2):102-11. doi: 10.1016/j.pscychresns.2015.05.007. Epub 2015 May 21.

Results Reference

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PubMed Identifier

22809824

Citation

Wing VC, Barr MS, Wass CE, Lipsman N, Lozano AM, Daskalakis ZJ, George TP. Brain stimulation methods to treat tobacco addiction. Brain Stimul. 2013 May;6(3):221-30. doi: 10.1016/j.brs.2012.06.008. Epub 2012 Jul 9.

Results Reference

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PubMed Identifier

25503588

Citation

Velez de Mendizabal N, Jones DR, Jahn A, Bies RR, Brown JW. Nicotine and cotinine exposure from electronic cigarettes: a population approach. Clin Pharmacokinet. 2015 Jun;54(6):615-26. doi: 10.1007/s40262-014-0221-7.

Results Reference

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PubMed Identifier

17255515

Citation

Naqvi NH, Rudrauf D, Damasio H, Bechara A. Damage to the insula disrupts addiction to cigarette smoking. Science. 2007 Jan 26;315(5811):531-4. doi: 10.1126/science.1135926.

Results Reference

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PubMed Identifier

24690001

Citation

Naqvi NH, Gaznick N, Tranel D, Bechara A. The insula: a critical neural substrate for craving and drug seeking under conflict and risk. Ann N Y Acad Sci. 2014 May;1316:53-70. doi: 10.1111/nyas.12415. Epub 2014 Apr 1.

Results Reference

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PubMed Identifier

19924591

Citation

Muller UJ, Sturm V, Voges J, Heinze HJ, Galazky I, Heldmann M, Scheich H, Bogerts B. Successful treatment of chronic resistant alcoholism by deep brain stimulation of nucleus accumbens: first experience with three cases. Pharmacopsychiatry. 2009 Nov;42(6):288-91. doi: 10.1055/s-0029-1233489. Epub 2009 Nov 18. No abstract available.

Results Reference

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PubMed Identifier

12154366

Citation

Craig AD. How do you feel? Interoception: the sense of the physiological condition of the body. Nat Rev Neurosci. 2002 Aug;3(8):655-66. doi: 10.1038/nrn894.

Results Reference

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Temporal Interference Neurostimulation and Addiction

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